Global Biomarker Lead, Inflammation, GI2 TAU

By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

As Associate Director/Director Global Biomarker Lead (GBL) Inflammation ED&B GI2 TAU you will

provide scientific and strategic leadership for the development and implementation of translational

biomarker strategies across preclinical and clinical-stage gastrointestinal and inflammation

portfolio programs. This highly visible strategic and matrixed role leads the Translational Sub-Team

(TST) and partners with GI-DDU research physician scientists and cross-functional stakeholders

to identify validate and implement biomarkers relevant to patients in clinical studies. The role is

responsible for independently developing translational biomarker plans as part of the overall asset

strategy across Discovery and Global Product Teams supporting programs through clinical

development and post-market activities and ensuring timely delivery of high-quality biomarker

data.

Key responsibilities:

Partner with GI-DDU discovery research and physician scientists to design and execute

translational research that identifies and validates targeted pathways based on human data

and defines candidate biomarkers for mechanism of action and drug response.

Lead translational biomarker strategy development and execution to support the clinical-

stage portfolio including biomarker-driven clinical study design implementation of novel

technologies and incorporation of biomarker endpoints for decision-making in early-stage

clinical trials.

Lead the Translational Sub-Team (TST) and provide matrix leadership across multiple

functional areas working closely with physician scientists clinical leads clinical

pharmacologists TBB nonclinical scientists and discovery research scientists to build

consensus around a fit-for-purpose biomarker strategy.

Represent Translational and Biomarker Research on Project and Global Product Teams to

provide pharmacodynamic disease and predictive biomarker strategy and support

translational medicine goals of the assigned programs in all phases of clinical

development.

Contribute as a key member of project teams that provide strategic technical and

scientific leadership for program progression from discovery research through development

and serve as a subject-matter expert for clinical development and overall asset strategies.

Implement fit-for-purpose validation for all clinical biomarker assays in partnership with the

biomarker assay group and ensure high scientific quality of pharmacodynamic prognostic

and predictive biomarker data to drive program decision-making. Evaluate and apply state-

of-the-art scientific tools and cutting-edge technologies to drive innovation in biomarker

strategy execution.

Maintain extensive knowledge of the research and development efforts from academic

institutions competitor biopharmaceutical companies and fee-for-service bioanalytical

CROs for translational biomarker research.

Responsible for the preparation and review of biomarker sections of candidate nomination

documents clinical protocols and documents submitted to Regulatory Agencies. Establish and maintain scientific dialogue with KOLs and clinical translational experts

across medical academic and regulatory communities.

Minimum Requirements/Qualifications:

PhD in a scientific discipline with 7 years of relevant experience.

Deep expertise in translational biomarkers and multi-omics approaches within immune-

mediated inflammatory diseases.

Demonstrated expertise in biomarker discovery biomarker development and translational

medicine as evidenced by publications regulatory submissions and/or national or

international presentations.

Excellent understanding of drug development regulatory processes and clinical

development.

Proven leadership ability including experience leading teams within a matrix organization

and working independently.

Strong analytical oral and written communication problem-solving and interpersonal

skills.